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NewTom DCiS
EUDAMEDClass IIa (EU MDR)
Ref 701FW011Model Digital radiograpy sensors
by CEFLA s.c.
Identity
- Trade Name
- NewTom DCiS EUDAMED
- Model / Reference
- Digital radiograpy sensors EUDAMED701FW011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837935797 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYINA001QX EUDAMED
- Direct Marketing DI
- 08033837935797 EUDAMED
- EMDN Code
- Z11030480 INSTRUMENTS FOR ENDORAL RADIOLOGY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NewTom DCiS by CEFLA s.c. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803383793IMXRAYINA001QX | Class IIa | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (1)
- EUDAMED 115185ac-6612-4f24-b53c-2c8e2b4dbaa7 61 fields · synced Jun 18, 2026